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FDA 510(k)

MIS C1 接入系统，MIS 七植入系统，MIS M4 接入系统，MIS Lance+ 接入系统，MIS Lance+ 锥形连接系统

K号: K251647 · 2025-08-21

申请人Dentsply Sirona, Inc.
决定日期2025-08-21
产品代码DZE
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决定实质等同

器械摘要

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K251647. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System?

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K251647.

When did MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System receive FDA 510(k) clearance?

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251647.

Who is the listed applicant for MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System?

FDA 510(k)记录中列出Dentsply Sirona, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System?

The FDA product code for MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System is DZE.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Dentsply Sirona, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261935外科和假肢托盘K260722SureSmile 矫正器 (ASSY500020)K253565SureSmile 软件K251614不锈钢手术包K253009DS Core DetectK250771Primescan 2

查看所有 22 个设备 →

相关器械（代码：DZE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261392TriActive 牙齿种植系统Paragon Implant Mfg., LLCK260463ZEROS 牙齿种植系统Zeros Co., Ltd.K251188UNIQA® 牙齿种植系统Uniqa Dental, Ltd.K251232MegaGen颧骨牙科植入系统Megagen Implant Co., Ltd.K250806牙科植入系统A.B. Dental Devices , Ltd.K260006INOSS 系统Inosys, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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